EFSA’s assessment of research into food additives and hyperactivity in children

17.3.2008

<div>The European Food Safety Authority, EFSA, has today published a statement on research published in 2007, which studied the effect of certain food colours and sodium benzoate on hyperactivity in children. Researchers from Southampton University have found a link between these additives and hyperactivity in children. The view of the EFSA is that the findings of the study could not be used as a basis for altering the Acceptable Daily Intake (ADI) values of the additives studied.</div>

The additives included in the study were the preservative sodium
benzoate (E211), and the food colours Tartrazine (E102), Quinoline
Yellow (E104), Sunset Yellow FCF (E110), Ponceau 4R (E124),
Allura Red AC (E129), and Azorubine or Carmoisine (E122). With the
exception of Quinoline Yellow, the food colours are azo dyes.

In its statement the EFSA concluded that the mixtures of
additives tested could slightly increase the activity of some
children. However, the effects observed were not statistically
significant in all cases. There were also many uncertainties
relating to the research findings. The findings were not consistent
in all respects, the effects found were relatively weak, and there
was an absence of information on the clinical significance of the
behavioural changes observed. Because the additives in the study
were used as mixtures, there was an inability to pinpoint which
individual additives were responsible for the effects observed. The
clinical significance of the effects observed remained unclear
since it was not known if the small changes in attention and
activity would affect schoolwork or other intellectual
functioning.

The EFSA did consider it possible, however, that certain
individuals might be sensitive to food additives in general or to
food colours in particular. However, it is not possible at present
to assess how widespread such sensitivity to additives might be in
the general population.

Children who consume sweets and soft drinks containing these
additives could actually reach intake levels for the additives
tested that would be similar to the amounts given in the study.

Southampton University study

The Southampton University study involved one hundred and fifty
three 3-year old and one hundred and forty four 8- to 9-year old
children. They were given three different drinks, one of which had
no additives and two had different mixtures of additives. After the
children had consumed the drinks, parents and teachers evaluated
the children’s behaviour according to standardized ratings. The
older children were also tested using a computerised test of
attention. Each drink was used for one week at a time, after which
there was a one-week break before moving on to the next drink. With
the three-year olds, one additive mixture increased hyperactivity
more than the placebo control drink, but the other additive mixture
had no effect. With the 8- to 9- year old children both of the
drinks containing additives increased the children’s hyperactivity
only when the children had consumed at least 85% of the drinks
offered. The authors concluded that synthetic colours and a sodium
benzoate preservative increase hyperactivity in 3-year old and 8-
to 9- year old children.

Taking the matter forward

In the European Union the Commission has the right of initiative
in legislative matters. On the basis of the EFSA’s safety
assessment the Commission will evaluate whether there are grounds
to change the rules concerning the use of additives. The EFSA is
currently re-assessing the safety of all permitted food colours,
and therefore the colours investigated in this study will also be
re-assessed. For some colours, such as Allura Red AC (E129), the
new assessments may already be completed during the course of this
year.

ADI, or Acceptable Daily Intake, refers to the maximum
acceptable intake of a substance per day, expressed by milligrams
(of the substance) per kilograms of body weight per day. The ADI
expresses the amount of the additive in question that a person can
consume in a day without a health risk.